FDA Says Johnson & Johnson's Covid Vaccine Has a 'Favorable Safety Profile'--Update
February 24 2021 - 9:08AM
Dow Jones News
By Thomas M. Burton and Peter Loftus
The U.S. Food and Drug Administration found that a Johnson &
Johnson Covid-19 vaccine was 66.1% effective in preventing moderate
to severe virus disease, and that it had a "favorable safety
profile."
In its clinical study of about 44,000 patients in the U.S.,
South Africa and other countries, the agency said, there were seven
Covid-19 deaths among patients getting a placebo, and none among
those who got the vaccine.
The finding appears to bolster J&J's earlier statements that
the vaccine is very effective in preventing severe disease.
The federal agency's analysis represents a key step toward a
possible FDA authorization of the vaccine as early as this weekend,
according to a person familiar with the matter.
A committee of outside medical specialists convenes Friday to
evaluate the analyses by both the FDA and the company, as the panel
did for the first two Covid-19 vaccines to be cleared for use.
The advisory committee is expected to recommend the FDA
authorize the J&J vaccine, and the agency is expected to make
its decision soon after.
The regulatory green light would bolster vaccination efforts
just as health authorities pick up the pace to get people back to
schools, offices and other establishments ahead of new strains that
threaten to evade medicines.
Health authorities expect the initial supply of the J&J
vaccine will help ease, though not eliminate, the frustration felt
by people unable to sign up for shots because there aren't enough
doses available.
J&J has said it would deliver about 20 million doses for
U.S. use by the end of March, which may be enough to boost the
countrywide capacity for completed vaccinations by about 20%.
The two other Covid-19 vaccines authorized in the U.S. come from
Moderna Inc. and from a partnership between Pfizer Inc. and
Germany's BioNTech SE. The companies have projected delivering
enough of their two-dose vaccines by the end of March to immunize
100 million people.
Each of those vaccines require two shots to confer their full
benefit. The J&J vaccine involves only one shot, a factor that
also may ease the logistics of delivering doses.
The late-stage study evaluating J&J's vaccine looked at how
well it protected against moderate and severe Covid-19 among
43,000-plus volunteers in several countries.
In the U.S. alone, the vaccine was 72% effective, J&J said.
The shot wasn't as effective in South Africa alone, where a new and
more transmissible variant of the virus has emerged. There, the
vaccine was 57% effective.
Those companies' trial results, however, occurred largely before
new variants are known to have emerged.
Several Covid-19 vaccine makers including Moderna and J&J
have said they are working on modified shots that could prove more
effective against new Covid-19 variants.
The expected FDA action is known as an emergency-use
authorization, a designation created by federal law to deal with
situations like the current global pandemic.
It falls short of a full FDA approval. Yet the FDA has
nevertheless required large clinical studies, as well as following
study volunteers for a median of two months following
vaccination.
J&J has said it expects to ship 100 million doses throughout
the U.S. by late June and to supply more than one billion doses
world-wide during 2021.
Pfizer and Moderna have committed to supplying enough doses by
the end of July to vaccinate 300 million people in the U.S.
Write to Thomas M. Burton at tom.burton@wsj.com and Peter Loftus
at peter.loftus@wsj.com
(END) Dow Jones Newswires
February 24, 2021 08:53 ET (13:53 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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